KIK Custom Products

Quality Systems Manager

US-NY-Cortland
7 days ago
Job ID
2017-4756
# of Openings
1
Division
KCM

Overview

 

Custom

 

The Quality Systems Manager oversees and manages the site’s Quality Systems including the documentation management systems; core divisional systems related to change management and the creation/revision controlled documents including protocols. The Quality Systems Manager manages and directs all activities in the Specification area to ensure efficient operation and all customer and regulatory procedures are followed and maintained. Other responsibilities include metrics; continuous improvement and managing inspection requests/document preparation room during regulatory and cGMP inspections. The Quality Systems Manager must be able to work professionally with internal staff and customers and external regulatory agencies. This position reports to the Quality Assurance Manager.

 

 

Essential Job Functions

 

  • Manage and coordinate the Specifications department to ensure accuracy of the documentation and the schedule is met
  • Administers the controlled document management system and ensures the system is optimized and enhanced as needed
  • Administers to the supporting systems that correlate to the Specifications department including LIMS® and JDE®
  • Provides guidance/training to user departments in proper use of the document management systems (Electronic and hard copy)
  • Implements and maintains document repositories and archives, develops and maintains archival systems

  • Responsible for maintaining the condition and security of archived controlled documents
  • Responsible for the management of core quality systems including SOPs, Change Management, Investigations, CAPA (not all inclusive) and continuous improvement opportunities for those systems
  • Manages the metrics and KPI's for the site
  • Manages master manufacturing batch records and protocol documentation
  • Manages document staging room during regulatory and customer inspections
  • Manages several direct reports who may also have direct reports
  • Counsels employees about work performance; develops and delivers performance reviews

 

 

Qualifications

 

  • Bachelor degree (or higher) in area of discipline
  • Minimum 5 years' experience in Quality Systems
  • Management Experience in FDA regulated manufacturing environment required.
  • Ideal experience in personal care, OTC or pharmaceuticals manufacturing
  • Experience in electronic documentation management systems (EDMS) (ie. Documentum, Trackwise, Master Control), Next Docs® is ideal
  • Intimate knowledge of document compliance and smart numbering
  • Familiarity with Batch Record Instructions and understanding of Specifications Change Control documents
  • Collaborative with an autonomous and self-sufficient work style.
  • Comfort in multi-tasking and managing multiple projects at once are a must.
  • Candidate must possess strong interpersonal, detail, and organizational skills

 

 

 

Thank you for your interest and consideration of a career with KIK Custom Products

 

 www.KIKCUSTOM.com

 

www.KIKCORP.com

 

KIK is an Equal Opportunity / Affirmative Action Employer

 

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